FDA Designates Fast Track Status for Apaziquone for Bladder Cancer
Enrollment is Expected to be Completed by Year End 2009
Spectrum Pharmaceuticals and Allergan, Inc. announced that the U.S. food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of apaziquone (EOquin®) for the treatment of non-muscle invasive bladder cancer, a form of bladder cancer localized in the surface layers of the bladder that has not spread to the deeper muscle layer.
“In a marker lesion study, where patients had previously failed multiple therapies, apaziquone produced a 67% complete response and was well-tolerated. We look forward to continuing with Phase 3 studies evaluating the efficacy and safety of apaziquone, while working with the FDA to expedite the drug’s development, review and approval process so we can help address the substantial unmet needs of patients suffering from non-muscle invasive bladder cancer,” said Rajesh C. Shrotriya, MD, Chairman, President, and Chief Executive Officer of Spectrum Pharmaceuticals.
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